2023-06-22 14:14:00
Respiratory syncytial virus (RSV) is the leading cause of pediatric respiratory infections worldwide and the second leading cause of death within the first year of life (after malaria). Every year it causes about 3.6 million hospitalizations and the death of 100,000 children under the age of 5. Over 60% of children are infected in the first year of life and almost 100%, at least once, within the second, with the risk of developing a serious infection such as bronchiolitis, which requires outpatient or hospital care and which can cause medium- and long-term sequelae. In Italy it is estimated that every year over 80,000 children in their first year of life are seen in the clinic for causes related to RSV infection, while around 15,000 need hospitalisation. Alarming data, according to neonatologists and pediatricians who hope “the concept of prevention based on vaccinations alone will be overcome and preventive monoclonal antibodies will also be included in national prevention strategies, as also recommended by the European Center for Disease Prevention and Control (Ecdc )”.
This is what emerged this morning during the event “A paradigm shift in the prevention of respiratory syncytial virus (RSV) in early childhood”, promoted on the initiative of the deputy Luciano Ciocchetti (FdI) at Palazzo Theodoli Bianchelli (Chamber of Deputies), which placed an important governance issue on the RSV prevention strategy in Italy on the agenda, also in light of the arrival of preventive monoclonal antibodies for passive immunization in the first year of life.
Organized by PharmaLex – formerly Mapcom, with the patronage of Fimp, Sihta, Siti and Sifo and the unconditional contribution of Sanofi Italia, the meeting stimulated an opportunity for open discussion between all the key players in the system, on the basis of new evidence clinical-epidemiological and economic-health available. The need for hospitalization – it emerged from the debate – is concentrated in the period of the epidemic peak, i.e. between November and March with a significant impact on hospital and territorial services. Most (88%) of newborns and children hospitalized for RSV are healthy babies born at the end of the gestational period, therefore not eligible for the current prophylaxis strategy which protects only babies born seriously preterm or with particular congenital pathologies.
During the event, Annamaria Staiano, president of Sip (Italian Society of Pediatrics), and Luigi Orfeo, president of Sin (Italian Society of Neonatology), presented the positions of scientific societies on the subject, contained in the Sip and Sin Manifesto “Prevention of pediatric infections from respiratory syncytial virus”, in which they hope that the concept of prevention based on vaccinations alone will be overcome and that preventive monoclonal antibodies will also be included in national prevention strategies, and therefore in the calendar.
Furthermore, the second edition of the Expert opinion “Respiratory syncytial virus (Vrs): prospects for a new prevention strategy for all children in the first year of life” was also presented to the institutional representatives, which outlined the prevention path for children in their first season of Rsv which involves the hospital setting for children born in the Rsv season (November-March) and the territory (free choice paediatricians and vaccination centres) for those born before the season.
“It seems appropriate to envisage a change of name of the National Vaccine Prevention Plan towards a National Immunization Plan – said Paolo Bonanni, full professor of General and Applied Hygiene, University of Florence and coordinator of the Board of the Vaccination Calendar for life – because it will be necessary to include monoclonal antibodies against RSV as a universal preventive measure, to offer protection to children during their first RSV season. In addition to the benefits in terms of public health and economics, this would allow inclusion in the Lea, and therefore a homogeneous offer throughout the national territory. Extending the prophylaxis strategy would, however, make it possible to reduce health events related to RSV, avoiding the related costs”.
In a study “forthcoming publication – explained Francesco Saverio Mennini, director of the Eehta Center of Ceis, University of Rome Tor Vergata and President Sihta – it is highlighted that a prevention strategy, with a monoclonal antibody, extended to all infants and children who experiencing their first RSV season would result in a reduction of over 100,000 (-46%) health events caused by acute RSV infection each year (outpatient doctor visits, emergency room visits and hospitalizations, recurrent bronchospasm and asthma). Added to this is an important reduction, equal to 39%, of deaths from RSV “. The “reduction of health events – underlined the expert – also corresponds to a significant economic advantage, quantified in a reduction in total spending of over 30 million euros each year compared to the current situation (-45%)”.
Even the WHO and the ECDC – it was reiterated during the conference – recommended to the national NItags (National immunization technical advisory groups) to extend, on the basis of scientific evidence, the concept of immunization to new preventive solutions, such as those represented by monoclonal antibodies, for infectious diseases that have an important impact in terms of public health. Some European countries, such as France and Spain, will implement an immunization strategy with the inclusion of monoclonal antibodies in the schedule, financed from the prevention budget, so that all children in the first year of life in their first RSV season can be equally protected .
“The innovations available from the research make possible a real paradigm shift in the public health approach to RSV prevention, in line with various international organizations – explained Carlo Signorelli, president of the National immunization technical advisory group (Nitag) and full professor of Hygiene and Public Health, Vita-Salute San Raffaele University, Milan – In Italy the new National Vaccine Prevention Plan 2023-25, currently under discussion within the State-Regions Conference, could be a stimulus for an increasingly effective approach based also on innovative approaches such as the preventive administration of monoclonal antibodies”.
Luciano Ciocchetti, vice president of the Chamber’s Social Affairs Commission said he was convinced of “firmly supporting initiatives such as the one presented today and of which I am a proud promoter. As a representative of the Parliament, I have made myself available to bring such a delicate and important issue into the spotlight for the entire country system. It is increasingly necessary to invest in public health so that a profound reform of the system takes place, with the ultimate goal of protecting everyone’s health, especially when it comes to children”.
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